{"active_ingredient":["Drug Facts Active ingredient ( in each tablet) Sodium bicarbonate 10 gr (650 mg)"],"ask_doctor":["Ask a doctor before use if you have a sodium restricted diet."],"ask_doctor_or_pharmacist":["Ask a doctor or pharmacist before use if you are taking a prescription drug. Antacids may interact with certain prescription drugs."],"dosage_and_administration":["​Directions do not use the maximum dosage for more than 2 weeks tablets may be swallowed whole or dissolved in water prior to use adults 60 years of age and over: 1-2 tablets every 4 hours, not more than 12 tablets in 24 hours adults under 60 years of age: 1-4 tablets every 4 hours, not more than 24 tablets in 24 hours"],"effective_time":"20260323","id":"4db6a586-dc28-33bb-e063-6394a90abc9b","inactive_ingredient":["Inactive ingredients croscarmellose sodium, microcrystalline cellulose, silica, stearic acid and talc"],"indications_and_usage":["Uses relieves: acid indigestion heartburn sour stomach upset stomach associated with these symptoms"],"keep_out_of_reach_of_children":["Keep out of reach of children."],"openfda":{"application_number":["M001"],"brand_name":["Sodium Bicarbonate Antacid"],"generic_name":["SODIUM BICARBONATE"],"manufacturer_name":["Aphena Pharma Solutions - Tennessee, LLC"],"original_packager_product_ndc":["0536-1047"],"package_ndc":["71610-669-53","71610-669-60","71610-669-80"],"product_ndc":["71610-669"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["198861"],"spl_id":["4db6a586-dc28-33bb-e063-6394a90abc9b"],"spl_set_id":["bba7d5bf-c94b-4ee4-a399-9a2818d84c78"],"substance_name":["SODIUM BICARBONATE"],"unii":["8MDF5V39QO"]},"other_safety_information":["Other information each tablet contains : sodium 178 mg store at room temperature 15º - 30º C (59º - 86º F)"],"overdosage":["In case of accidental overdose, seek professional assistance or contact a Poison Control Center immediately."],"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL - 650 mg NDC 71610-669 - Sodium Bicarbonate 10gr (650 mg) Tablets label"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding , ask a health professional before use."],"purpose":["Purpose Antacid"],"questions":["Questions or comments? 1-800-645-2158"],"set_id":"bba7d5bf-c94b-4ee4-a399-9a2818d84c78","spl_product_data_elements":["Sodium Bicarbonate Antacid Sodium Bicarbonate CROSCARMELLOSE SODIUM CELLULOSE, MICROCRYSTALLINE STEARIC ACID SILICON DIOXIDE TALC SODIUM BICARBONATE SODIUM CATION CPC77"],"spl_unclassified_section":["TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING Distributed by: Rugby Laboratories 17177 N Laurel Park Drive, Suite 233 Livonia, MI 48152 www.rugbylaboratories.com Rev. 12/16 R-29","Repackaging Information Please reference the HOW SUPPLIED section listed above for a description of individual drug products listed below. This drug product has been received by Aphena Pharma Solutions - Tennessee, LLC in a manufacturer or distributor packaged configuration and repackaged in full compliance with all applicable cGMP regulations. The package configurations available from Aphena are listed below: 10gr (650mg) NDC 71610-669-53, Bottles of 60 Tablets NDC 71610-669-60, Bottles of 90 Tablets NDC 71610-669-80, Bottles of 180 Tablets Store between 20°-25°C (68°-77°F). See USP Controlled Room Temperature. Dispense in a tight light-resistant container as defined by USP. Keep this and all drugs out of the reach of children. Repackaged by: Cookeville, TN 38506 20260323BSC Aphena"],"stop_use":["Stop use and ask a doctor if symptoms last more than 2 weeks"],"version":"3","warnings":["Warnings Do not take more than 24 tablets for adults up to 60 years of age (or 12 tablets for adults 60 yeasr of age and older) in a 24-hour period nor use the maximum dosage for more than 2 weeks, except under the advice and supervision of a physician. Ask a doctor before use if you have a sodium restricted diet. Ask a doctor or pharmacist before use if you are taking a prescription drug. Antacids may interact with certain prescription drugs. Stop use and ask a doctor if symptoms last more than 2 weeks If pregnant or breast-feeding , ask a health professional before use. Keep out of reach of children. In case of accidental overdose, seek professional assistance or contact a Poison Control Center immediately."]}